Quality Analyst IReq # JR - 025166 Location Opelika, Alabama, United States Additional Locations 40 Job Category Quality Control Date posted 07/29/2020
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Conducts reviews of documentation and reports for conformance to procedures, protocols, and regulatory requirements. Ensures training effectiveness in production. Provide Quality support with assigned projects and/or audits to ensure manufacturing goals and project deadlines are met while maintaining compliance with current good manufacturing practices (GMPs), environmental health and safety (EHS) guidelines and any other regulations that could apply.
Essential Duties and Responsibilities. This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.
- Responsible for reviewing documents, records and reports against Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on
- regulatory requirements and internal guidelines, etc.
- Supports initial investigative actions on post market complaints as well as some NCRs, applying well-established techniques and procedures.
- Create or revise standard procedures.
- Maintain relevant databases. Prepare and issue reports as defined as well as develop custom reports as needed.
- Assist in external and internal audits by maintaining audit records, extracting data from databases, and creating reports, collecting relevant data, etc.
- Conduct training needs analysis for specific employee groups.
- Design, develop, implement and deliver specific on the job training and development initiatives.
- Uses prescribed performance and learning tools, concepts, and models to mentor and coach on the job trainers.
- Measure and monitor training program effectiveness
- Support learning and development activities for new hires, contractors and employees.
- Analyze training data and participate in learning and development continuous improvement efforts to improve performance
- Maintain accurate training records and reporting
Physical Requirements: Physical requirements for a position will vary. These must be reviewed with the supervisor and should be attached here.
- Duties may require overtime work, including nights and weekends.
- Use of hands and fingers to manipulate office equipment is required.
- Position requires standing and walking for extended periods of time.
Qualifications. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.
- Working knowledge of medical products.
- Excellent computer skills.
- Knowledge of JDE.
- Good communication, written and oral skills.
- Knowledge of regulations outside United States a plus.
- Self-motivated with the ability to work both collaboratively and independently.
- Ability to drive decisions and actions.
- Excellent organizational skills, problem solving skills, and attention to detail.
- Ability to perform multiple tasks simultaneously and work cross-functionally in a highly-matrixed environment.
- Expertise in interpreting regulations and familiarity with GDP and GMP.
- Experience with working in an environment subject to compliance with 21 CFR Parts 7, 11, 803, 806, 810, 820 strongly preferred.
- Solid analytical and system thinking skills
- Good presentation and group facilitation skills
- Knowledgeable of adult learning
- Good instructional design skills
- Interact with all levels of personnel to analyze and solve problems related tomanufacturing, Quality, documentation, and human performance issues.
- Work in and facilitate a team-oriented environment.
- Excellent customer service skills
Education and/or Experience
- BS in science or equivalent
- 0-3 year's experience of manufacturing experience or equivalent manufacturing experience
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.